RecruitingNCT04854278

Introduction of an Operating Room Black Box to Identify, Analyse and Prevent Errors in the Vascular Hybrid Room

Development of Strategies to Identify, Analyse and Prevent Errors in the Vascular Hybrid Room - an Inter-professional Approach to Enhance Technical and Non-technical Performance and to Improve Patient Safety


Sponsor

University Ghent

Enrollment

400 participants

Start Date

Feb 19, 2019

Study Type

OBSERVATIONAL

Conditions

Summary

The "OR Black box", an inclusive multiport data capturing system has been developed and successfully used for detailed analysis of laparoscopic surgical procedures. A pilot study has shown that this system can be successfully installed in the hybrid room at Ghent University Hospital and used for detailed analysis of intra-operative errors and radiation safety issues in endovascular procedures. Secondary analysis of pilot study data via direct video coding assessed the relationship between leadership style of the surgeon and team behavior and possible fluctuations during surgery. This novel approach allows a prospective objective assessment of human and environmental factors as well as measurement of errors, events and outcomes. In this study, the aim is to use the acquired knowledge to characterize a chain of events, identify high-risk interventions and identify areas for improvement, both on an organizational, team or individual level. Hypothesis: non-technical skills, environmental factors and teamwork in the hybrid room correlate with surgical technical performance and error rates. Furthermore, we hypothesize that incidents and adverse events can be tracked to a chain of errors that is influenced by technical and non-technical skills as well as environmental factors.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This Belgian study introduces an operating room 'black box' — a recording and monitoring system similar to those used in aircraft cockpits — into a vascular hybrid operating room to capture surgical team behavior, communication, and technical performance during endovascular procedures. The goal is to identify human and technical factors that contribute to errors or near-misses, in order to improve surgical safety and training. Patients undergoing planned (elective) endovascular procedures for vascular disease — including treatment of blocked or narrowed arteries in the legs and pelvis, or aortic aneurysm repair — will be enrolled. All members of the surgical team must also consent to monitoring. You may be eligible if: - You are 18 years or older - You are scheduled for an elective endovascular procedure (planned more than 48 hours in advance) - Your procedure treats atherosclerotic vascular disease (blocked arteries in the aorta, iliac, femoral, popliteal, or below-knee vessels) or involves endovascular repair of a thoracic or abdominal aortic aneurysm (EVAR) - Both you and all team members have consented to recording You may NOT be eligible if: - You have not consented to the black box recording - Any member of the surgical team has not consented - Your procedure is an emergency (planned less than 48 hours in advance) - Your procedure treats a condition other than the specified vascular diseases or aneurysms Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

OTHERMassive Open Online Course (MOOC)

Combination of knowledge training with video scenarios and game-based learning provided to endovascular team members: surgeons, nurses and anesthetists


Locations(1)

UZ Gent

Ghent, Oost-Vlaanderen, Belgium

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT04854278


Related Trials